Increlex

What is Increlex?

Increlex is a prescription medicine that is used to help children grow.

Description

INCRELEX (mecasermin) injection contains human insulin-like growth factor-1 (rhIGF-1) produced by recombinant DNA technology. IGF-1 consists of 70 amino acids in a single chain with three intramolecular disulfide bridges and a molecular weight of 7649 daltons. The amino acid sequence of the product is identical to that of endogenous human IGF-1. The rhIGF-1 protein is synthesized in bacteria (E. coli) that have been modified by the addition of the gene for human IGF-1.

INCRELEX is a sterile, aqueous, clear and colorless solution intended for subcutaneous injection. Each multi-dose vial of INCRELEX contains 10 mg per mL mecasermin, 9 mg per mL benzyl alcohol, 5.84 mg per mL sodium chloride, 2 mg per mL polysorbate 20, and 0.05M acetate at a pH of approximately 5.4.

Mechanism of Action

Insulin-like growth factor-1 (IGF-1) is a key hormonal mediator on statural growth. Under normal circumstances, growth hormone (GH) binds to its receptor in the liver, and other tissues, and stimulates the synthesis/secretion of IGF-1. In target tissues, the Type 1 IGF-1 receptor, which is homologous to the insulin receptor, is activated by IGF-1, leading to intracellular signaling which stimulates multiple processes resulting in statural growth. The metabolic actions of IGF-1 are in part directed at stimulating the uptake of glucose, fatty acids, and amino acids so that metabolism supports growing tissues.

Before taking Increlex, tell your doctor:

• If your child is allergic to Increlex; any part of this medicine; or any other drugs, foods, or substances. Tell the doctor about the allergy and what signs your child had.
• If your child has or has ever had cancer, has a health problem that raises the risk of cancer, or has a family member who has had cancer.
• If your child’s bones are no longer growing (closed epiphyses).
• If the patient is a newborn or infant. This medicine has benzyl alcohol in it. Benzyl alcohol may cause severe and sometimes deadly side effects in newborns or infants. Do not give Increlex to a newborn or infant.

This is not a list of all drugs or health problems that interact with this medicine.

Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take Increlex with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.

What are some things I need to know or do while I take Increlex?

• Tell all of your child’s health care providers that your child is taking Increlex. This includes your child’s doctors, nurses, pharmacists, and dentists.
• Have your child avoid tasks or actions that call for alertness for 2 to 3 hours after getting Increlex and until you see how Increlex affects your child. This includes things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
• If your child has high blood sugar (diabetes), talk with the doctor. This medicine may lower blood sugar. High blood sugar drugs may need to be changed.
• Have your child’s blood sugar checked as you have been told by your child’s doctor.
• Have your child’s blood work checked often. Talk with your child’s doctor.
• Raised pressure in the brain may rarely happen.
• Get your child an eye exam as you have been told by the doctor.
• If a child is using Increlex, monitor growth carefully.
• If your child has an abnormal curve in the spine (scoliosis), talk with your doctor. This medicine could make it worse in children who are still growing.
• This medicine may cause high cholesterol and triglyceride levels. Talk with the doctor.
• Cases of cancer have happened in children taking Increlex. It is not known if Increlex caused this effect. If you have questions, talk with your child’s doctor.
• Allergic reactions have happened with Increlex. Sometimes, these have been very bad and people have had to go to the hospital. Talk with the doctor.

If your child is pregnant or breast-feeding a baby:

• Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks to your child and the baby.

How is Increlex best taken?

Give Increlex as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into the fatty part of the skin in the upper arm, thigh, buttocks, or stomach area.
• If you will be giving your child the shot, your child’s doctor or nurse will teach you how to give the shot.
• This medicine must be given within 20 minutes of your child’s meal or snack.
• If your child is not able to eat, do not give a dose and do not make up for the missed dose.
• Wash your hands before and after use.
• Move the site where you give the shot with each shot.
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not use if solution changes color.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

• Skip the missed dose and go back to your child’s normal time.
• Do not give 2 doses at the same time or extra doses.

What are the side effects of Increlex that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Dizziness or passing out.
• Pale skin.
• Clammy skin.
• Change in eyesight.
• Snoring.
• Breathing problems during sleep (sleep apnea).
• Larger tonsils.
• Ear pain.
• Change in hearing.
• Headache.
• Upset stomach or throwing up.
• Hip or knee pain, or a limp.
• Seizures.
• Thick skin, pits, or lumps where the injection was given.
• A heartbeat that does not feel normal.
• Low blood sugar may occur. Signs may be dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating. Call the doctor right away if any of these signs occur. Follow what you have been told to do if low blood sugar occurs. This may include taking glucose tablets, liquid glucose, or some fruit juices.

What are some other side effects of Increlex?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:

• Joint pain.
• Bruising.
• Irritation where the shot is given.
• Pain in arms or legs.

These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Increlex?

• Store in a refrigerator. Do not freeze.
• Protect from light.
• Do not use if it has been frozen.
• After opening, throw away any part not used after 1 month.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL – 40 MG VIAL CARTON

• IPSEN
• Rx only
• increlex®
  (mecasermin) injection
• 40 mg/4 mL
  (10 mg/mL)
• For subcutaneous use only
• Net wt. 40 mg